Quantitative Assessment of Acute Regurgitation Following Transcatheter Aortic Valve Replacement: A Multicenter Pooled Analysis of 2,258 Valves

Abstract Background Regurgitation following transcatheter aortic valve replacement (TAVR) impacts all-cause mortality. Thus far, no quantitative comparison of regurgitation amongst multiple commercially available transcatheter heart valves (THV) has been performed. Objectives We sought to assess the acute regurgitation following TAVR comparing different implanted THV. Methods Aortograms from a multicenter cohort of consecutive 3,976 TAVR were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core lab using videodensitometry. Results of quantitative regurgitation are shown in percentage. Valves evaluated were: Acurate (n=115), Centera (n=11), CoreValve (n=532), Direct Flow Medical (n=21), Evolut Pro (n=95), Evolut R (n=295), Inovare (n=4), Lotus (n=546), Lotus Edge (n=3), Sapien XT (n=239) and Sapien 3 (n=397). For the main analysis only valves with more than 50 procedures (7 types) were used. Results Lotus valve had the lowest mean regurgitation (3.5±4.4%), followed by Evolut Pro (7.4±6.5%), Sapien 3 (7.6±7.1%), Evolut R (7.9±7.4%), Sapien XT (8.8±7.5%), Acurate (9.6±9.2%) and CoreValve (13.7±10.7%, ANOVA p-value Conclusion In this pooled analysis stemming from daily clinical practice, the Lotus valve showed to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core lab (non-sponsored) in a real-world cohort of patients using a quantitative technique.